The Use of Lactobacillus Reuteri in Functional Constipation in Children

NCT03333070 | Terminated DMC

• 1 other identifier: 0042-17-EMC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Functional constipation (FC) is a common condition in childhood, with an estimated prevalence of 0.7% to 29%.The diagnosis and treatment of FC can be difficult tasks, and children are often referred to specialist services causing treatment to become expensive and time-consuming.The standard treatment based on osmotic laxatives (mainly PEG). The recovery rate is 50% to 60% after 1 year of treatment, with 50% of the children having relapse within 5 years. Studies in adults have established the effectiveness of some lactic acid bacteria in the treatment of chronic constipation.

Conditions

Functional Constipation

Outcome Measures

Primary Outcomes (4)

• The prevalence of constipation recurrence

  according to Rome IV criteria

  This measure will be assessed at weeks 24.

• The prevalence of constipation recurrence

  according to Rome IV criteria

  This measure will be assessed at weeks 60.

• failure of maintaining normal bowel movements without PEG and the need to resume PEG treatment

  according to Rome IV criteria

  This measure will be assessed at weeks 24.

• failure of maintaining normal bowel movements without PEG and the need to resume PEG treatment

  according to Rome IV criteria

  This measure will be assessed at weeks 60.

Secondary Outcomes (3)

• The number of bowel movements per week

  This measure will be assessed at baseline and at 24, 36, 48 and 60 weeks after enrolment

• The number of episodes of fecal incontinence per week

  This measure will be assessed at baseline and at 24, 36, 48 and 60 weeks after enrolment

• The stool consistency in patients without PEG treatment

  This measure will be assessed at baseline and at 24, 36, 48 and 60 weeks after enrolment

Study Arms (2)

Treatment Arm

ACTIVE COMPARATOR

25 consecutive children diagnosed with functional constipation will be treated with full dose PEG (Polyethylene glycol 3350) treatment (dose of \~1g/kg/day) for 12 weeks. After 12 weeks of treatment they will be randomized: treated arm will receive probiotic containing Lactobacillus reuteri for 12 weeks while tapering the PEG dose Dose of 5 drops per day for 48 weeks

Dietary Supplement: probiotic - Lactobacillus reuteri

Placebo Arm

PLACEBO COMPARATOR

25 consecutive children diagnosed with functional constipation will be treated with full dose PEG (Polyethylene glycol 3350) treatment (dose of \~1g/kg/day) for 12 weeks. After 12 weeks of treatment they will be randomized: control arm will receive placebo for 12 weeks while tapering the PEG dose Dose of 5 drops per day for 48 weeks

Other: placebo - with no active ingredient

Interventions

probiotic - Lactobacillus reuteri DIETARY_SUPPLEMENT

The treated arm will receive 5 drops per day for 48 weeks

Treatment Arm

placebo - with no active ingredient OTHER

The control arm will receive 5 drops per day for 48 weeks

Placebo Arm

Eligibility Criteria

• Age: 6 Months - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 0.5 - 15 years
• Diagnosis of functional constipation according to Rome IV criteria

You may not qualify if:

• Children with chronic diseases which could cause constipation: Celiac disease, food allergy, Hypothyroidism, Inflammatory Bowel Disease, electrolytes disturbances, Cystic fibrosis, Hirschsprung disease, Neuropathic conditions (Spinal cord trauma, Neurofibromatosis, Tethered cord) or intestinal pseudo-obstruction.
• Prematurity (\< 34 weeks)
• S/P intestinal surgery
• Children treated with medications associated with constipation.
• Existing malignancy
• Primary or secondary immunodeficiency

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Emek medical center

Afula, Israel

Location

Study Officials

• Sarit Peleg, MD

  Emek Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: November 6, 2017
• Study Start: June 26, 2018
• Primary Completion: June 26, 2018
• Study Completion: June 26, 2018
• Last Updated: October 4, 2018

Record last verified: 2018-10

Locations

IL (1)